Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2021 to June 2022 and laboratory testing personnel interview on August 4, 2022, it was determined that the laboratory failed to maintain a copy of the proficiency testing event records. The findings include: 1. The PRPTP records were reviewed from February 2021 to June 2022. 2. On August 4, 2022 at 9:48 AM, the PRPTP records showed that the laboratory did not have the following proficiency testing records for February 2021, March, 2021, April 2021, May 2021, June 2021, September 2021, October 2021, November 2021 and December 2021. 3. The laboratory testing personnel confirmed on August 4, 2022 at 11:43 AM, that those proficiency testing event records were not available in the laboratory. D2128 HEMATOLOGY CFR(s): 493.851(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2021 to June 2022 and laboratory testing personnel interview on August 4, 2022, it was determined that the laboratory failed to take and document